Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K050332 |
Device Name |
SURGI-WRAP MAST BIORESORBABLE SHEET |
Applicant |
MAST BIOSURGERY USA INC. |
6749 TOP GUN ST., SUITE C |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
KENNETH K KLEINHENZ |
Correspondent |
MAST BIOSURGERY USA INC. |
6749 TOP GUN ST., SUITE C |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
KENNETH K KLEINHENZ |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 02/10/2005 |
Decision Date | 05/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|